Devices and methods for guiding and applying traction to a patients leg during surgery

ABSTRACT

A system for supporting and manipulating a leg of a patient including a base configured to be releasably secured to the ground, a first guide rail coupled to the base, wherein the first guide rail has a longitudinal axis, a boot coupled to the first guide rail, wherein the boot is configured to receive and retain at least a portion of a foot of the patient, and a drape hanger assembly coupled to the base, wherein the drape hanger assembly includes a pair of drape hangers oriented parallel to the longitudinal axis of the first elongate guide rail.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. provisional patent applicationSer. No. 61/923,453 filed Jan. 3, 2014, and entitled “Devices andMethods for Guiding and Applying Traction to a Patient's Leg DuringSurgery,” which is hereby incorporated herein by reference in itsentirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

BACKGROUND

Embodiments described herein relate generally devices and methods forsupporting and manipulating a patient's leg and foot during surgery(e.g., hip joint surgery) or diagnostic procedure. More specifically,embodiments described herein relate to devices and methods for guidingand applying traction to a patient's leg during surgery or diagnosticprocedure.

During surgery on a patient's leg (e.g., hip or knee surgery), certainpositions and orientations of the leg may be preferred by the surgeon.For example, during one phase of hip surgery, the surgeon may want toplace the patient's leg in tension (i.e., traction), whereas in anotherphase of hip surgery, the surgeon may want to rotate the patient's legabout a certain axis while maintaining traction. Moreover, in somecases, the surgeon may want to maintain traction or a particularrotational orientation of the patient's leg while adjusting the other.For example, during a hip replacement surgery, the patient typicallylies on an operating table having a leg holding and support deviceattached thereto. The leg holding and support exerts tension on thepatient's leg while holding the patient's leg in one or more desiredpositions to facilitate the surgery.

Some conventional leg holding and support devices enable traction to beapplied to the patient's leg, but provide limited, if any, ability tosimultaneously rotate the patient's leg about one or more axes. Otherconventional leg holding and support devices enable rotation of thepatient's leg about one or more axes, but do not provide the ability toindependently control and adjust the rotation of the patient's leg aboutdifferent axes. Still other conventional leg holding and support devicesenable traction and rotation of the patient's leg about an axissimultaneously, but do not allow adjustment of one while maintaining theother.

BRIEF SUMMARY OF THE DISCLOSURE

A system for supporting and manipulating a leg of a patient includes abase configured to be releasably secured to the ground, a first elongateguide rail coupled to the base, wherein the first elongate guide railhas a longitudinal axis, a boot moveably coupled to the first elongateguide rail, wherein the boot is configured to receive and retain atleast a portion of a foot of the patient, and a drape hanger assemblycoupled to the base and configured to support a drape, wherein the drapehanger assembly includes a pair of drape hangers oriented parallel tothe longitudinal axis of the first elongate guide rail, wherein the pairof drape hangers are disposed on opposite sides of the first elongateguide rail in top view.

A system for supporting and manipulating a leg of a patient includes abase, a post having a first end coupled to the base and a second enddistal the base, a carrier pivotally coupled to the second end of thepost, wherein the carrier is configured to pivot about a horizontal axisrelative to the post, a first guide rail coupled to the carrier andconfigured to pivot with the carrier relative to the post, wherein thefirst guide rail has a longitudinal axis, a second guide rail pivotallycoupled to the first guide rail, wherein the second guide rail isconfigured to move axially along the first guide rail, and a bootmoveably coupled to the second guide rail, wherein the boot isconfigured to receive and retain at least a portion of a foot of thepatient.

A system for supporting and manipulating a leg of a patient independentof a table or bed includes a base including a body and a pair ofstabilizer arms pivotally coupled to the body, wherein each stabilizerarm has a first end pivotally coupled to the body and a second enddistal the body, and wherein the stabilizer arms are configured to pivotabout the first ends, a pad coupled to the second end of each stabilizerarm, wherein each pad comprises a suction device configured toreleasably secure the second end of the corresponding stabilizer arm tothe ground, and a boot moveably coupled to the base, wherein the boot isconfigured to receive and retain at least a portion of a foot of thepatient.

Embodiments described herein comprise a combination of features andadvantages intended to address various shortcomings associated withcertain prior devices, systems, and methods. The foregoing has outlinedrather broadly the features and technical advantages of the invention inorder that the detailed description of the invention that follows may bebetter understood. The various characteristics described above, as wellas other features, will be readily apparent to those skilled in the artupon reading the following detailed description, and by referring to theaccompanying drawings. It should be appreciated by those skilled in theart that the conception and the specific embodiments disclosed may bereadily utilized as a basis for modifying or designing other structuresfor carrying out the same purposes of the invention. It should also berealized by those skilled in the art that such equivalent constructionsdo not depart from the spirit and scope of the invention as set forth inthe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a detailed description of the preferred embodiments of theinvention, reference will now be made to the accompanying drawings inwhich:

FIG. 1 is a perspective view of an embodiment of a leg support andmanipulation system in accordance with the principles disclosed herein;

FIG. 2 is a front view of the system of FIG. 1;

FIG. 3 is a rear view of the system of FIG. 1;

FIG. 4 is a top view of the system of FIG. 1;

FIG. 5 is a front perspective view of the support assembly of the systemof FIG. 1;

FIG. 6 is a rear perspective view of the support assembly of FIG. 5;

FIG. 7 is a top view of the support assembly of FIG. 5;

FIG. 8 is a cross-sectional view of the support assembly of FIG. 5 takenalong section 8-8 in FIG. 7;

FIG. 9 is a perspective view of a rail assembly of the system of FIG. 1;

FIG. 10 is a top view of the rail assembly of FIG. 9;

FIG. 11 is a side view of the rail assembly of FIG. 9;

FIG. 12 is another side view of the rail assembly of FIG. 9;

FIG. 13 is a perspective view of the locking apparatus of the railassembly of FIG. 9;

FIG. 14 is a front view of the locking apparatus of FIG. 13;

FIG. 15 is a side view of the locking apparatus of FIG. 13;

FIG. 16 is a cross-sectional view of the rail assembly of FIG. 9 takenalong section 16-16 of FIG. 10;

FIG. 17 is an enlarged partial perspective view of the rail assembly ofFIG. 9;

FIG. 18 is a perspective view of a foot holder assembly of the system ofFIG. 1;

FIG. 19 is another perspective view of the foot holder assembly of FIG.18;

FIG. 20 is another perspective view of the foot holder assembly of FIG.18;

FIG. 21 is a front view of the foot holder assembly of FIG. 18;

FIG. 22 is a cross-sectional view of the foot holder assembly of FIG. 18taken along section 22-22 of FIG. 21;

FIG. 23 is an enlarged partial perspective view of the cross-sectionalview of FIG. 22 of the foot holder assembly of FIG. 17;

FIG. 24 is a cross-sectional view of the foot holder assembly of FIG. 18taken along section 24-24 of FIG. 18;

FIG. 25 is an enlarged partial view of the cross-sectional view of FIG.22;

FIG. 26 is an enlarged partial front view of FIG. 21;

FIG. 27 is an enlarged partial perspective view of the cross-sectionalview of FIG. 22;

FIG. 28 is a cross-sectional view of the foot holder assembly of FIG. 18taken along section 22-22 of FIG. 21 illustrating a sterile drapeconfiguration in accordance with the principles disclosed herein;

FIG. 29 is a front view of the leg support and manipulation system ofFIG. 1 in a first or upper position, illustrating the sterile drapeconfiguration of FIG. 28; and

FIG. 30 is a front view of the leg support and manipulation system ofFIG. 1, in a second or lower position illustrating the sterile drapeconfiguration of FIG. 28.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following discussion is directed to various exemplary embodiments.However, one skilled in the art will understand that the examplesdisclosed herein have broad application, and that the discussion of anyembodiment is meant only to be exemplary of that embodiment, and notintended to suggest that the scope of the disclosure, including theclaims, is limited to that embodiment.

Certain terms are used throughout the following description and claimsto refer to particular features or components. As one skilled in the artwill appreciate, different persons may refer to the same feature orcomponent by different names. This document does not intend todistinguish between components or features that differ in name but notfunction. The drawing figures are not necessarily to scale. Certainfeatures and components herein may be shown exaggerated in scale or insomewhat schematic form and some details of conventional elements maynot be shown in interest of clarity and conciseness.

In the following discussion and in the claims, the terms “including” and“comprising” are used in an open-ended fashion, and thus should beinterpreted to mean “including, but not limited to.” Also, the term“couple” or “couples” is intended to mean either an indirect or directconnection. Thus, if a first device couples to a second device, thatconnection may be through a direct connection, or through an indirectconnection via other devices, components, and connections. In addition,as used herein, the terms “axial” and “axially” generally mean along orparallel to a central axis (e.g., central axis of a body or a port),while the terms “radial” and “radially” generally mean perpendicular tothe central axis. For instance, an axial distance refers to a distancemeasured along or parallel to the central axis, and a radial distancemeans a distance measured perpendicular to the central axis. Further, asused herein, the terms “bed” and “table” refer to a patient's bed,operating table, examination bed, or any other bed used for medicalprocedures, operations, care, diagnostics, or combinations thereof.

Referring now to FIGS. 1-4, an embodiment of a leg support andmanipulation system 10 is shown. System 10 is configured to selectivelyand controllably secure, hold, support, manipulate, position, and orienta patient's leg during a surgical or diagnostic procedure. During such aprocedure, the patient is positioned on a bed or operating table, andthe system 10 is positioned adjacent the end of the table to hold andsupport one of the patient's legs. Thus, contrary to many conventionalleg support and manipulation devices, system 10 is “freestanding.” Inother words, during a patient procedure, system 10 is separate andspaced apart from the table. In general, system 10 can be used tosupport and manipulate the patient's leg undergoing the procedure,referred to herein as the “affected” leg, or the patient's opposite leg(i.e., the patient's leg that is not the subject of the procedure),referred to herein as the “unaffected” leg. As will be described in moredetail below, in this embodiment, system 10 facilitates a sterileoperating environment with the use of a sterile drape, and further,system 10 is modular such that individual assemblies and components ofsystem 10 may be selectively and independently sterilized.

Leg support and manipulation system 10 is generally configured to standalone and independently support the patient's affected leg.Specifically, system 10 is configured to support the patient's affectedleg without being coupled or in physical engagement with an operatingtable, the patient's bed, or any other device. Thus, system 10 isconfigured to support the patient's affected leg independently of theoperating table and/or the patient's bed.

Referring still to FIGS. 1-4, in this embodiment, leg support andmanipulation system 10 includes a support assembly 100 moveably disposedon the ground, a rail assembly 200 coupled to the support assembly 100,and a foot holder assembly 300 coupled to the rail assembly 200. Duringa procedure, the patient's foot is secured to foot holder assembly 300,which is moveably coupled to a rail assembly 200 and supported by thesupport assembly 100. Support assembly 100, rail assembly 200, footholder assembly 300, or combinations thereof can then be employed toposition and manipulate the patient's foot and ankle to adjust andachieve the desired position and orientation of the patient'scorresponding leg (affected or unaffected leg), as well as controllablyapply fraction to the patient's corresponding leg.

Referring now to FIGS. 5-8, support assembly 100 allows system 10 to bemoved and positioned at the desired location along the ground (e.g.,floor of operating room), and then releasably locked and secured at thatdesired location. Consequently, support assembly 100 transfers the loadapplied by the rail assembly 200, foot holder assembly 300, and thepatient's leg to the ground. In this embodiment, support assembly 100includes a base 110, a first or forward pair of arms 120 extendinghorizontally from base 110, a second or rearward pair of arms 130extending horizontally from base 110, a pair of stabilizers 140pivotally coupled to base 110, and a post assembly 160 extendingvertically upward from base 110. Arms 120 extend in the same directionfrom base 110 and are laterally spaced apart; arms 130 extend in theopposite direction from base 110 as arms 120 and are laterally spacedapart.

Each forward arm 120 has a first or fixed end 120 a fixably secured tobase 110 and a second or free end 120 b distal base 110. A wheel orcaster 124 is pivotally coupled to the free end 120 b of each forwardarm 120 with a vertical shaft (not shown) seated in a mating receptaclein the bottom of the end 120 b, which allows the caster 124 to freelyrotate relative to the corresponding end 120 b about a vertical axis125. Each caster 124 includes a pair of wheels 126 and a lock 128configured to releasably lock wheels 126. Each pair of wheels 126 areconfigured to roll along the ground about a horizontal axis. Each lock128 has a locked position preventing wheels 126 from rolling along theground (i.e., preventing wheels 126 from rotating about the horizontalaxis) and an unlocked position allowing wheels 126 to roll along theground (i.e., allow wheels 126 to rotate about the horizontal axis).

In this embodiment, each lock 128 is manually transitioned between thelocked and unlocked positions via a foot pedal that can be depressed andraised by the foot of one or more operating room personnel. However, inother embodiments each lock 128 may be mechanically actuated throughother mechanisms (e.g., a lock rotated into a locked position by hand).In still other embodiments, each lock 128 may be actuated electrically,hydraulically, or through other means known in the art using anactuator. In general, locks 128 can comprise any wheel locking mechanismknown in the art. Although locks 128 function to releasably lock wheels126 to prevent rotation about the horizontal axes in this embodiment, inother embodiments, the locks (e.g., locks 128) simultaneously lock thewheels to prevent rotation about both the horizontal axis and thevertical axis (e.g., axis 125).

Referring still to FIGS. 5-8, rear arms 130 have a first or fixed end130 a fixably secured to base 110 and a second or free end 130 b distalbase 110. A caster 124 is pivotally coupled to free end 130 b of eacharm 130. Casters 124 coupled to arms 130 are the same as casters 124previously described.

Arms 120 have a horizontal length measured between ends 120 a, 120 b,and arms 130 have a horizontal length measured between ends 130 a, 130b. In this embodiment, the horizontal length of each arm 120 is thesame, and the horizontal length of each arm 130 is the same. Inaddition, the horizontal length of each arm 120 is greater than thehorizontal length of each arm 130.

Referring still to FIGS. 5-8, stabilizers 140 are disposed betweenforward arms 120 and rearward arms 130 and extend laterally fromopposing sides of base 110. Stabilizers 140 provide added stability tosystem 10 and releasably secure system 10 to the ground so that it isprevented from moving once disposed at the desired position during use.In this embodiment, each stabilizer includes a first end 140 a moveablycoupled to base 110 and a second or free end 140 b distal base 110. Asbest shown in FIG. 8, the first end 140 a of each stabilizer 140 iscoupled to base 110 at a pivot point 142, which allows the stabilizer140 to rotate up and down about a horizontal axis extending throughpivot point 142. Thus, each stabilizer 140 can pivot about its end 140 abetween a refracted or raised position with distal end 140 b spacedabove the ground and a deployed or lowered position with distal end 140b firmly seated against the ground. Each stabilizer 140 can bereleasably locked in the raised or deployed position for example by alocking pin or lever.

A pad 144 is disposed at free end 140 b of each stabilizer 140. Thus,when stabilizers 140 are deployed, pads 144 are seated against theground to provide lateral support and stability to system 10. Moreparticularly, pads 144 are configured to stabilize system 10 againstreaction forces produced by the patient's affected leg during use ofsystem 10 (e.g., when fraction is applied to the affected leg withsystem 10). In this embodiment, pads 144 are suction devices that arereleasably secured to the ground via formation of a low pressure regionrelative to the surrounding ambient pressure. In particular, each pad144 includes an outer housing 146, a suction cup 148 disposed withinhousing 146, an actuator 152 pivotally coupled to end 140 b, and acoupling link 150 extending between actuator 152 and cup 148. The bottomof each housing 146 is open to allow the corresponding suction cup 148to access and engage the ground therebelow. Each actuator 152 is a footor hand operated lever having a first end 152 a distal the correspondinghousing 146 and a second end 152 b engaging the upper surface of thecorresponding housing 146. Each actuator 152 is pivotally coupled to end140 b of the corresponding stabilizer 140 proximal second end 152 b.Second end 152 b of each actuator 152 comprises a cam surface thatslidingly engages the top of the corresponding housing 146. Each pad 144and actuator 152 can be described as having a “locked” position with end152 a rotated downward and pad 144 firmly secured to the ground (FIG. 8)and an “unlocked” position with end 152 a rotated upward and pad 144released from the ground (i.e., not firmly secured to the ground). Withstabilizers 140 in the deployed positions, pads 144 and actuators 152are transitioned between the locked and unlocked positions by rotatingends 152 a downward and upward respectively.

In particular, with each stabilizer 140 deployed and the correspondingactuator 152 in the unlocked position, the flexible suction cups 148 arepressed flat or substantially flat against the ground. The annularradially outer edge or lip 148 a of each suction cup 148 is held inplace by the annular rim at the lower end of the corresponding housing146. When each actuator 152 is transitioned to the locked position bypivoting the corresponding end 152 a downward towards the ground (e.g.,by pushing down on end 152 a), the corresponding link 150 is pulledupward, thereby pulling the radially inner portions of the correspondingsuction cup 148 upward away from the ground. With the lip 148 a of eachcup 148 held against the ground with housing 146, as the radially innerportion of each cup 148 is raised upward, a vacuum or low pressureregion (relative to the outside ambient environment) is formed therein(i.e., between the ground and the suction cup 148). Such a vacuum or lowpressure region within the cup 148 restricts and/or prevents thecorresponding cup 148 and pad 144 from moving relative to the ground,thereby securing that pad 144 and system 10 to the ground. To unlockeach pad 144, the corresponding actuator 152 is pivoted about end 152 bby urging end 152 a upward away the ground (e.g., by pushing up on end152 a), thereby pushing the corresponding link 150 downward toward theground and pushing the radially inner portion of the corresponding cup148 downward flat or substantially flat against the ground. As suctioncup 148 is pushed to the ground, the low pressure regions within the cup148 is relieved, thereby equalizing the pressure within suction cup 148and the surrounding ambient environment and allowing the correspondingpad 144 to be moved relative to the ground.

In this embodiment, each actuator 152 is a manually operated lever thatis transitioned between the locked and unlocked positions by depressingend 152 a or raising end 152 a with the user's foot. However, in otherembodiments, the stabilizer pads (e.g., pads 144) are transitionedbetween the locked and unlocked positions by other means such as via apersonal interface, a switch, computer, or other device operable forapplying a vacuum to the pads 140. In such embodiments, anelectronically controlled air pump can be employed to generate andrelieve the pressure differential.

Post assembly 160 extends vertically upward from base 110 and has avertically oriented central or longitudinal axis 165, a first or upperend 160 a distal base 110, and a second or lower end 160 b releasablysecured to base 110 with a coupling 116. In addition, post assembly 160includes a tubular outer post 162 and an inner post 164 slidinglyreceived in outer post 162. Outer post 162 has a first or upper end 162a and a second or lower end 162 b defining end 160 b of post assembly160. Inner post 164 is coaxially disposed within outer post 162 and hasa first or upper end 164 a extending from upper end 162 a of outer post162 and a second or lower end 164 b disposed within outer post 162.Upper end 164 a defines upper end 160 a of post assembly 160. In thisembodiment, inner post 164 can be controllably moved axially up and downrelative to outer post 162 and base 110, thereby vertically and axiallyextending and contracting post assembly 160. In other words, the axiallength of post assembly 160 and the axial position of end 160 a, 164 arelative to base 110 can be varied and adjusted as desired bytelescopically extending or refracting inner post 164 relative to outerpost 162. Once the desired axial position of upper end 160 a relative tolower end 160 b is achieved, the axial position of inner post 164relative to outer post 162, and hence the axial position upper end 160a, 164 a can be releasably locked. As best shown in FIGS. 10, 11, 13,and 14, in this embodiment, post assembly 160 is vertically extended andrefracted with an actuator 163 comprising a manually operated hand crankthat can be rotated in one direction to extend post assembly 160 (i.e.,move inner post 164 upward relative to outer post 162) and rotated inthe opposite direction to contract post assembly 160 (i.e., move innerpost 164 downward relative to outer post 162). In particular, in thisembodiment, inner post 164 is displaced axially (up and down) via athreaded shaft disposed therein and coupled to actuator 163. Rotation ofactuator 163 causes the threaded shaft to rotate. The shaft threadablyengages a mating block fixably coupled to outer post 162. Thus, rotationof the shaft relative to the block causes inner post 164 to movevertically relative to outer post 162. The mating internal threads ofthe block and external threads of the shaft are self-locking such thatthey do not slide or move relative to each other unless actuator 163 isrotated. In this embodiment, post assembly 160 is a spindle liftingcolumn similar to the lifting columns produced by LINAK U.S. Inc., 2200Stanley Gault Parkway, Louisville, Ky. 40223. Although post assembly 160is a spindle lifting column extended and contracted by manually rotatingan actuator 163 in this embodiment, in general, post assembly 160 can beextended and refracted by any suitable means known in the art including,without limitation, a gear and toothed rack, a linear actuator (e.g.,pneumatic or hydraulic piston cylinder assembly), etc.

Referring now to FIGS. 1 and 9-12, rail assembly 200 is coupled to upperend 160 a of post assembly 160 (upper end 164 a of inner post 164) andsupports, positions, and orients foot holder assembly 300 relative tosupport assembly 100. For purposes of clarity, foot holder assembly 300is not shown in FIGS. 9-12. In this embodiment, rail assembly 200includes a hub or base 202 coupled to upper end 160 a of post assembly160, a carrier 230 pivotally coupled to base 202, a first elongate guiderail 250 fixably coupled to carrier 230, and a second elongate guiderail 260 moveably coupled to first guide rail 250. As will be describedin more detail below, foot holder assembly 300 can be controllably movedand locked along second guide rail 260, second guide rail 260 can becontrollably moved and locked along first guide rail 250, and carrier230 can be controllably pivoted and locked relative to base 202 toadjust the angular orientation of guide rails 250, 260 relative to base202. Although guide rails 250, 260 can pivot relative to base 202 fromvertical and horizontal orientations, respectively, first guide rail 250is generally vertically oriented and second guide rail 260 is generallyhorizontally oriented. Accordingly, first guide rail 250 may also bereferred to as “vertical” guide rail 250 and second guide rail 260 mayalso be referred to as “horizontal” guide rail 260.

Referring still to FIGS. 9-12, in this embodiment, base 202 includes arigid outer housing 204, a rotatable horizontal shaft 208 extendingthrough housing 204, and a locking apparatus 214 disposed within housing204 and coupled to shaft 208. Housing 204 has a first or upper end 204 adistal upper end 164 a of post 164 and a second or lower end 204 bfixably mounted to upper end 164 a of the inner post 164. Thus, housing204 does not move translationally or rotationally relative to inner post164. As will be described in more detail below, a drape hanger assembly222 is removably coupled to upper end 204 a of housing 204.

Referring now to FIGS. 9-16, housing 204 (except for lower end 204 b) ishidden for clarity to better illustrate shaft 208 and locking apparatus214. Shaft 208 has a horizontally oriented central axis 205, a first orouter end 208 a coupled to an actuation or operating handle 210, and asecond or inner end 208 b coupled to carrier 230. As best shown in FIGS.10 and 16, second end 208 b of shaft 208 is pivotally coupled to carrier230 with a pin 212. In particular, carrier 230 comprises a block 232 anda pair of arms 234 extending from block 232. Arms 234 are disposed onopposite sides of end 208 b of shaft 208 and have aligned bores thatreceive the ends of pin 212. Pin 212 has a central axis 213 thatintersects and is oriented perpendicular to axis 205. Pin 212 allowsshaft 208 to transfer rotational torque to carrier 230 about axis 205while simultaneously allowing carrier 230 to pivot about axis 213relative to base 202. Thus, handle 210 can be rotated within a verticalplane to apply rotational torque to carrier 230 via shaft 208 and pin212, thereby enabling an operator of system 10 to controllably rotateshaft 208 and carrier 230 in either direction about horizontal axis 205.

Referring briefly to FIGS. 11-13, in this embodiment, handle 210 isextendable (i.e., has a length that can be varied). In particular,handle 210 includes a tubular outer handle 210 a that extends generallydownward from end 208 a of shaft 208 and an inner handle 210 b disposedslidingly disposed within outer handle 210 a. Thus, inner handle 210 bcan be telescopically extended from and retracted into outer handle 210a Inner handle 210 b is biased by gravity to a retracted positionsubstantially disposed within outer handle 210 a. It should beappreciated that by extending handle 210 b from outer handle 210 a, theoperator of system 10 has greater leverage to apply torque to shaft 208(i.e., a larger moment arm). Thus, unless needed for applying additionaltorque to shaft 208, inner handle 210 b is generally disposed withinouter handle 210 a and will not obstruct an operator attempting tooperate other components of system 10. Outer handle 210 a has a lengthsufficient to receive substantially the entire length of inner handle210 b. Due to the length of outer handle 210 extending towards theground, the operator of system 10 can also apply rotational torque toshaft 108 by acting on outer handle 210 a with the operator's leg, knee,or foot. In this manner, the operator may apply substantial torque toshaft 208 without needing to actuate handle 210 using the operator'shands. As will be described in more detail below, carrier 230 can becontrollably pivoted about axis 213 in either direction independent ofthe rotation of shaft 208 and carrier 230 about axis 205. Thus, in thisembodiment, carrier 230 can be controllably pivoted relative to base 202and post assembly 160 about two separate axes 205, 213. Axis 205 lies ina horizontal plane oriented perpendicular to axis 165 of post assembly160, and axis 213 lies in a vertical plane oriented perpendicular toaxis 205. Therefore, in top view (shown in FIG. 10), axes 205, 213 areperpendicular. Shaft 208, and hence carrier 230, can be rotated ineither direction about axis 205 relative to base 202, and carrier 230can be rotated in either direction about axis 213.

Referring now to FIGS. 13-15, locking apparatus 214 releasably locks therotational/angular position of shaft 208, and hence carrier 230, aboutaxis 205 relative to housing 204 and support assembly 100. In otherwords, locking apparatus 214 has an “unlocked” position (shown in FIGS.13-15) allowing rotation of shaft 208 about axis 205, and a “locked”position preventing the rotation of shaft 208 about axis 205. Regardlessof whether locking apparatus 214 is in the locked or unlocked position,carrier 230 can pivot freely about axis 213 of pin 212. In thisembodiment, locking apparatus 214 includes a cam sleeve 216 fixablymounted to shaft 208 between ends 208 a, 208 b, a rocker arm 218pivotally coupled to housing 204, and a locking lever 220 forcontrollably pivoting arm 218 relative to housing 204 and cam sleeve216. The lower end of cam sleeve 216 includes a plurality ofcircumferentially spaced teeth 216 a, each tooth 216 a being disposed atthe same radius from axis 205. Rocker arm 218 has a first end 218 apivotally coupled to housing 204 at a pivot point 218 c and a second end218 b opposite first end 218 a. Thus, end 218 b of rocker arm 218 can bepivoted up and down about end 218 a and a horizontal axis extendingthrough pivot point 218 c. A rocker arm 218 also includes a lockingmember 218 d positioned between ends 218 a, 218 b. Locking member 218 dis sized and positioned to releasably engage a pair of circumferentiallyadjacent teeth 216 a of cam sleeve 216. Engagement of locking member 218d with teeth 216 a prevents rotation of shaft 208, and disengagement oflocking member 218 d and teeth 216 a allows rotation of shaft 208. Thus,locking apparatus 214, rocker arm 218, and locking member 218 d have a“locked” position with member 218 d engaging adjacent teeth 216 a and an“unlocked” positioned with member 218 d disengaged and spaced from teeth216 a. As will be described in more detail below, in this embodiment,locking member 218 d is biased upward into engagement with teeth 216 a,and thus, locking apparatus 214, rocker arm 218, and locking member 218d are biased to the locked position.

Locking lever 220 transitions locking apparatus 214, rocker arm 218, andlocking member 218 b from the locked position to the unlocked position.In particular, locking lever 220 has a first or upper end 220 aextending vertically from upper end 204 a of housing 204 and a second orlower end 220 b pivotally coupled to rocker arm 218 proximal second end218 b. Upper end 220 a comprises a knob 220 c that can be grasped by theoperator of system 10 to actuator locking apparatus 214. Thus, theoperator can press knob 220 c downward to pivot rocker arm 218 aboutpoint 218 c and rotate locking member 218 d downward out of engagementwith teeth 216 a, thereby unlocking shaft 208. A spring return 220 ddisposed about lever 220 biases lever 220 upward, thereby biasinglocking member 218 d upward into engagement with teeth 216 a.

Referring now to FIGS. 9-12, 16, and 17, a locking pin 236 releasablylocks carrier 230 relative to pin 212. As will be described in moredetail below, locking pin 236 has a “locked” position preventing carrier230 from rotating about axis 213 and an “unlocked” position allowingcarrier 230 to rotate freely about axis 213. A balancing assembly 280applies a balancing force on first rail 250, and hence a balancingtorque on carrier 230, to balance the weight of rail 260, foot holderassembly 300 and the patient's leg once it is strapped into foot holderassembly 300 and locking pin 236 is transitioned to the unlockedposition. In particular, the weight of rail 260, assembly 300, and thepatient's affected leg provide a first moment or torque on carrier 230in a first rotational direction 231 at least partially defined by thedistance of their collective center of mass from axis 213 of carrier230. To balance against this first torque on carrier 230 when pin 236 isunlocked, balancing assembly 280 provides a second moment or torque oncarrier 230 in a second direction 233 opposite direction 231. Thus,balancing assembly 280 is configured to counterbalance or substantiallycounterbalance the first moment (i.e., torque applied to carrier 230 bythe weight of rail 260, assembly 300, and the patient's affected leg).Thus, when pin 236 is unlocked, very little to no force or torque needsto be applied to carrier 230 to overcome the weight of rail 260, footholder assembly 300, and the patient's leg in order to rotate carrier230 about axis 213 in second direction 233. As a result, carrier 230 isgenerally free to “follow” the leg of the patient coupled to foot holderassembly 300, such that the patient or operator of system 10 may easilyadjust the position of the patient's affected leg without the need toapply substantial force or torque.

Locking pin 236 is provided to selectively prevent carrier 230 fromrotating downward in first direction 231 about axis 213, therebyreleasably locking the rotational position of carrier 230 about axis213. As best shown in FIGS. 16 and 17, in this embodiment, locking pin236 includes a first or upper end 236 a, a second or lower end 236 b, ahandle 238 disposed at upper end 236 a for axially displacing lockingpin 236, and an elongate engagement block or member 240 disposed atlower end 236 b for selectively engaging the second end 208 b of shaft208. In particular, engagement member 240 includes a convex surface 240a configured to engage a mating concave recess 208 c of shaft 208.Locking pin 236 has an “unlocked position” (shown in FIG. 16) withlocking pin 236 displaced axially upwards using handle 238 to removemember 240 from recess 208 c of shaft 208, thereby allowing freerotation of carrier 230 about axis 213 in either direction 231, 233; anda “locked” position with pin 236 displaced axially downwards andengagement member 240 seated in mating recess 208 c of shaft 208,thereby preventing rotation of carrier 230 about axis 213 in eitherdirection 231, 233.

Referring still to FIGS. 9-12 and 16, in this embodiment, balancingassembly 280 includes a hydraulic piston-cylinder damper 281, a firstadapter 282 coupling damper 281 to shaft 208, and a second adapter 283coupling damper 281 to first rail 250. Damper 281 has a central axis285, a first or upper end 281 a, and a second or lower end 281 b. Ends281 a, 281 b can move axially toward and away from each other, therebyaxially contracting and extending damper 281. First adapter 282 has afirst or upper end 282 a fixably secured to shaft 208 between housing204 and carrier 230 and a second or lower end 282 b pivotally coupled toupper end 281 a of damper 281 with a pinned connection 284. Secondadapter 283 has a first end 283 a fixably secured to first rail 250distal carrier 230 and a second end 283 b pivotally coupled to lower end281 ba of damper 281 with a pinned connection 284. As previouslydescribed, balancing assembly 280 balances the torque on carrier 230, tobalance the weight of rail 260, foot holder assembly 300 and thepatient's leg once it is strapped into foot holder assembly 300 andlocking pin 236 is transitioned to the unlocked position. In addition,balancing assembly 280 dampens and smooths the rotation of carrier 230about axis 213 in both rotational directions 231, 233. In particular, asends 281 a, 281 b move axially relative to each other (extension andcontraction), damper 281 dampens such movement, thereby slowing andsmoothing the movement of ends 281 a, 281 b relative to each other, andhence, slowing and smoothing the rotation of carrier 230 about axis 213in both rotational directions 231, 233.

Referring now to FIGS. 9, 11, 12, and 16, vertical guide rail 250 has acentral or longitudinal axis 255, a first or fixed end 250 a fixablycoupled to block 232, and a second or free end 250 b distal block 232.As shown in the cross-sectional view of FIG. 16, vertical guide rail 250includes an outer rail 252, a flexible belt 254 (e.g., nylon belt,Kevlar belt, chain, etc.) disposed within rail 252, a sprocket 256rotatably coupled to fixed end 250 a, and a crank 258 fixably coupled tothe sprocket 256. Guide rail 250 also includes a second sprocket (notshown) at free end 250 b. Belt 254 engages and extends around firstsprocket 256 and the second sprocket. Crank 258 is rotated (in eitherdirection) to drive the rotation of sprocket 256, which is in turn movesbelt 254 around the sprockets. In this embodiment, crank 258 is manuallyrotated by the operator of system 10; however, in other embodimentssprocket 256 may be driven by an actuator, such as a hydraulic actuatoror an electric motor, etc. As will be described in more detail below,horizontal guide rail 260 is coupled to belt 254, and thus, as belt 254moves around the sprockets, horizontal guide rail 260 moves axially(relative to axis 255) along guide rail 250. Crank 258 can be rotated ineither direction to move horizontal guide rail 260 up or down alongguide rail 250, as desired.

Displacement of horizontal guide rail 260 along rail 250 and rotation ofcrank 258 can be selectively locked via actuation of a locking member277. Specifically, locking member 277 is configured to selectively andreleasably prevent downward displacement of rail 260 along rail 250 viaphysical engagement between locking member 277 and a pin 258 a (FIG. 17)of hand crank 258 that extends towards horizontal rail 260 along an axisparallel with axis 213. In this embodiment, locking member 277 ispivotally coupled to carrier 230 and includes a first or upper end 277a, a second or lower end 277 b, and a pinned joint 277 c pivotably orrotatably coupled to carrier 230. Pinned joint 277 c defines an axis ofrotation for locking member 277 that is parallel to axis 213. Lockingmember 277 includes a recess or notch 277 d for releasably engaging pin258 a. In this embodiment, notch 277 d is sized and shaped to preventrotation of crank 258 in one direction, lowers rail 260 (generallyparallel to first direction 231), when pin 258 a is seated therein, butallows free rotation of crank 258 in the opposite direction (generallyparallel to second direction 233) even when pin 258 a is seated therein.

In this embodiment, upper end 277 a of locking member 277 is biasedforward toward pin 258 a via a biasing member (not shown). Thus, whenhand crank 258 is rotated in a direction parallel to direction 233 for asingle revolution, pin 258 a will slidingly engage locking member 277and pass through notch 277 d as it moves towards lower end 277 b.However, when hand crank 258 is rotated in a direction parallel todirection 231 for a single revolution, pin 258 a will slidingly engagelocking member 277 as it moves toward upper end 277 a, but willpositively engage notch 277 d, thereby restricting further rotation ofhand crank 258 in the direction parallel to direction 231. In order tofurther rotate hand crank 258 in the direction parallel to direction231, locking member 277 end 277 a is pulled backward away from pin 258 a(in a direction parallel to direction 233) from the locked position withpin 258 a seated in notch 277 d to the unlocked position (shown in FIG.17) with notched 277 d pulled away from pin 258 a, thereby releasing pin258 a of crank 258. As previously described, locking member 277 andnotch 277 d are biased toward pin 258 a, but can be pivoted to theunlocked position by pulling a knob 277 f disposed at upper end 277 a oflocking member 277. In this manner, pin 258 a of hand crank 258 willengage notch 277 d of locking member 277 for each individual rotation ofcrank 258.

In this embodiment, locking member 277 interfaces with a radio frequencyidentification (RFID) lock 279 (hidden in FIG. 16), which is configuredto selectably or releasably lock the angular or rotational position oflocking member 277, thereby preventing rotation of hand crank 258 ineither angular direction 231, 233. RFID lock 279 includes a retractablepin 279 a that extends along an axis parallel with axis 213 and isconfigured to physically engage an indentation 277 g that extends intolocking member 277 at lower end 277 b. In particular, pin 279 a includesan unlocked position where pin 279 a is retracted into RFID lock 279 anda locked position where pin 279 a is axially extended into indentation277 g of locking member 277, thereby preventing rotation of lockingmember 277 about pinned joint 277 c. RFID lock 279 is configured totransition between the unlocked and locked positions in response to anelectromagnetic signal transmitted between lock 279 and an RFID tag, asare known in the art, configured to communicate with lock 279. The RFIDlock 279 may be configured to transition between the locked position tothe unlocked position for a predetermined period of time in response tothe transmission of an electromagnetic signal between lock 279 and anRFID lock. RFID tags may also be configured to unlock RFID lock 279 apredetermined number of times.

Referring now to FIGS. 9-12 and 16-21, horizontal guide rail 260 has acentral or longitudinal axis 265, a first end 260 a pivotally coupled toguide rail 250, and a second or free end 260 b distal vertical guiderail 250. First end 260 a is pivotally coupled to a mounting block 262with a pinned connection 264 that allows guide rail 260 to pivotrelative to mounting block 262 about a horizontal axis 267. Inparticular, pinned connection 264 allows guide rail 260 to pivot upwardabout axis 267 from a default position oriented perpendicular tovertical guide rail 250 and pivot downward about axis 267 to the defaultposition oriented perpendicular to vertical guide rail 250. In otherwords, guide rail 260 cannot rotate below the default position orientedperpendicular to guide rail 250. In this embodiment, guide rail 260 maypivot freely about axis 267 (i.e., there is no resistance to therotation of guide rail 260 about axis 267). However, in otherembodiments, the horizontal guide rail (e.g., guide rail 260) includes alocking mechanism to selectively and releasably lock pivoting of thehorizontal rail relative to the vertical rail (e.g., rail 250).

Mounting block 262 is fixably secured to belt 254 of first guideassembly 250, and thus, as block 262 moves up and down relative to outerrail 252, horizontal guide rail 260 moves up and down relative to outerrail 252. In this embodiment, mounting block 262 is fixably secured tobelt 254 with a clamp 272. Thus, by rotating the sprocket 256 via handcrank 258, belt 254 is advanced around sprocket 254 to displace mountingblock 262 axially along vertical guide rail 250—when hand crank 258 isrotated in one direction, mounting block 262 moves toward end 250 a ofvertical guide rail 250, and rotation of sprocket 256 in the oppositeangular direction moves mounting block 262 toward end 250 b of guiderail 250. Once the desired position of mounting block 262 along verticalguide rail 250 is achieved, block 262 can be locked relative to guiderail 250 by locking belt 254 as previously described. Horizontal guiderail 260 supports foot holder assembly 300 (not shown in FIGS. 9-12),and allows foot holder assembly 300 to move axially along its length.

Referring now to FIGS. 18-24, foot holder assembly 300 includes a slideblock or carriage 310 slidably mounted to guide rail 260 and a boot 350pivotally coupled to carriage 310. A drive assembly 330 controllablymoves carriage 310 axially (relative to axis 265 of rail 260) in eitherdirection along guide rail 260 (i.e., toward end 260 a or end 260 b). Inthis embodiment, carriage 310 includes a housing 312 slidingly engagingguide rail 260 and a post 314 extending upward from housing 312. Post314 has a first or upper end 314 a pivotally coupled to boot 350 with arotatable coupling 316, a second or lower end 314 b coupled to housing312 with a mount assembly 318, and a pivot joint assembly 320 disposedbetween ends 314 a, 314 b. Pivot joint assembly 320 includes a pivotjoint 320 a that allows end 314 a, and hence boot 350 coupled thereto,to pivot freely relative to lower end 314 b about an axis 321 disposedin a vertical plane oriented perpendicular to axis 265. In thisembodiment, pivot joint 320 a allows end 314 a, and hence boot 350, topivot about axis 321 relative to lower end 314 b through a limited angleθ measured counterclockwise in FIG. 22 from a position with post 314oriented perpendiculars to rail 260. Angle θ is preferably limited to 0°to 30°, where 0° corresponds to the position shown in FIGS. 18-22 withpost 314 perpendicular to rail 260, and 30° corresponds to rotation 30°(from 0°) toward carrier 230.

Mount assembly 318 includes a fixed block 325 secured to the top ofcarriage 310, a slider block 326 slidably and releasably coupled tofixed block 325, and a quick release coupling 327 releasably couplingthe lower end 314 b of post 314 to slider block 326. Thus, tworeleasable connections are provided between boot 350 and carriage310—the coupling between blocks 325, 326 and the quick release coupling327 between post 314 and slide block 326. In this embodiment, blocks325, 326 are releasably coupled with a sliding dovetail joint thatallows slider block 326 to slide axially (parallel to axis 265). Amanually operated lock 328 has an unlocked position allowing sliderblock 326 to be slid along fixed block 325 and a locked positionpreventing slider block 326 from moving relative to fixed block 325.Thus, with lock 328 in the unlocked position, block 326 can be movedalong block 325 to the desired position, and then lock 328 transitionedto the locked position preventing relative movement between blocks 325,326. As best shown in FIG. 24, quick release coupling 327 includes a pin329 received within a mating receptacle 326 a in the top of slider block326 and a locking pin 329 that releasably locks pin 329 withinreceptacle 326 a. When pin 329 is disposed in receptacle 326 a, pin 329and hence boot 350 can rotate freely about the central axis of pin 329relative to slider block 326, fixed block 325, and carriage 310. Pin 329has a first or fixed end 329 a fixably secured to lower end 314 b ofpost 314, a second or free end 329 b opposite end 329 a, and a radiallyextending flange 329 c disposed between ends 329 a, 329 b. Flange 329 chas a planar upper surface 329 d and a frustoconical or tapered lowercam surface 329 e. Locking pin 331 extends through slider block 326 intoreceptacle 326 a. In this embodiment, the inner end of pin 331 is biasedinto receptacle 326 a with a biasing member 331 a (e.g., a coil spring).To make up quick release coupling 327, thereby coupling boot 350 tocarriage 310 and rail 260, pin 329 is inserted into receptacle 326 a.Cam surface 329 e slides along the inner end of locking pin 331 disposedin receptacle 326 a and pushes locking pin 331 outward, thereby allowingpin 329 to be fully seated in receptacle 326 a. Once flange 329 c isdisposed below locking pin 331, biasing member 331 a pushes locking pin331 back into receptacle 326 a, thereby preventing pin 329 from beingpulled out of receptacle 326 a while allowing pin 329 to rotate therein.To remove pin 329 from receptacle 326 a, thereby decoupling boot 350from carriage 310 and rail 260, locking pin 331 is pulled outward so itsinner end no longer engages flange 329 c, and then pin 329 is pulledfrom receptacle 326 a.

As best shown in FIG. 22, in this embodiment, drive assembly 330includes a drive screw or spindle gear 332 rotatably disposed withinhousing 312 and a drive block housing 334 disposed within housing 312.Drive block housing 334 is fixably secured to guide rail 260 with bolts336 such that drive block housing 334 cannot move relative to rail 260.However, as will be described in more detail below, housing 312 can bemoved axially along rail 260 relative to drive block housing 334.

Referring now to FIGS. 22 and 23, spindle gear 332 extends axially(parallel to axis 265) through housing 312 and has a first end 332 arotatably coupled to a first end 312 a of housing 312 and a second end332 b rotatably coupled to a second end 312 b of housing 312. Thus,spindle gear 332 can rotate relative to housing 312 but cannot moveaxially relative to housing 312. In other words, spindle gear 332 andhousing 312 move axially (relative to axis 265) together. Thecylindrical outer surface of spindle gear 332 comprises externalthreads. In this embodiment, a hand crank 338 (FIGS. 18-21) is coupledto spindle gear 332 and can be used to manually rotate spindle gear 332.In other embodiments, different actuation means can be provided torotate the spindle gear (e.g., spindle gear 332) such as an electricmotor.

Referring still to FIGS. 22 and 23, a spindle 335 is slidably receivedin drive block housing 334 and threadably coupled to spindle gear 332.In particular, spindle 335 has a first end 335 a proximal an end wall334 b of housing 334, a second end 335 b opposite the first end 335 a,and an internally threaded bore 335 c extending axially (parallel toaxis 265) between ends 335 a, 335 b. Spindle gear 332 extends throughbore 335 c of spindle 335 and housing 334, and has external threads thatmate and engage internal threads in bore 335 c. Thus, relative rotationbetween spindle 335 and spindle gear 332 causes spindle 335 and spindlegear 332 to move axially (parallel to axis 265) relative to each other.

Spindle 335 includes an annular flange 335 d at first end 335 a thatextends radially outward and housing 334 includes an annular shoulder334 a axially opposed flange 335 d. A pair of annular washers 337 a, 337b are disposed about spindle 335 and axially positioned (relative toaxis 265) between flange 335 d and shoulder 334 a. As will be describedin more detail below, frictional engagement between flange 335 d,washers 337 a, 337 b, and shoulder 334 a allows the transfer of torquebetween spindle 335 and drive block housing 334.

A ball bearing 339 is disposed within drive block housing 334 aboutspindle gear 332. Bearing 339 includes a radially outer race 339 aengaging spindle 335, a radially inner race 339 b disposed within outerrace 339 a, and a plurality of circumferentially-spaced balls 339 crotatably disposed between races 339 a, 339 b. Balls 339 c generallyallow races 339 a, 339 b to rotate freely relative to each other. Anannular slip or slide ring 332 d is radially positioned between bearing339 and spindle gear 332. Ring 332 d slidingly engages spindle gear 332.In particular, ring 332 d has a smooth cylindrical inner surfacedisposed at a diameter greater than or equal to the outermost reaches ofthe external threads of spindle gear 332 such that ring 332 d contactsbut is free to slide axially over spindle gear 332 and the externalthreads thereon. Outer race 339 a radially abuts and is seated againstan inner cylindrical surface of spindle 335 at first end 335 a such thatouter race 339 a and spindle 335 do not move relative to each other. Anannular biasing member 341 is also disposed within drive housing 334about spindle gear 332. Biasing member 341 is axially positioned betweenend wall 334 b of housing 334 and inner race 339 b, and generally urgesbearing 339, spindle 335, and washers 337 a, 337 b axially (parallel toaxis 265) away from end wall 334 b of housing 334, thereby biasingflange 335 d axially against washers 337 a, 337 b, which in turn arebiased against shoulder 334 a of housing 334. Spindle gear 332 can berotated in either direction about its central axis with crank 338 tomove carriage 310, and hence boot 350 coupled thereto, axially back andforth along rail 260.

In particular, the axial force applied by biasing member 341 generatesfrictional loads between flange 335 d and shoulder 334 a (via washers337 a, 337 b) that restrict and/or prevent relative rotationtherebetween. In other words, frictional engagement between flange 335 dof spindle 335, washers 337 a, 337 b, and shoulder 334 a due to biasingmember 341 maintains spindle 335 rotationally stationary relative todrive block housing 334 as spindle gear 332 rotates therein. As a resultof the threaded engagement of spindle gear 332 and spindle 335, rotationof spindle gear 332 in a first direction relative to spindle 335 andhousing 334 causes carriage 310 to move in a first axial direction 310 a(toward end 260 b and away from end 260 a) and rotation of spindle gear332 in a second direction relative to spindle 335 and housing 334 causescarriage 310 to move in a second axial direction 310 b (toward end 260 aand away from end 260 b). Slip ring 332 d slidingly engages spindle gear332 and allows spindle gear 332 to move axially therethrough as spindlegear 332 rotates to move carriage 310 axially along rail 260. In thismanner, crank 338 can be used to adjust the axial position of carriage310, and boot 350 coupled thereto, along rail 260.

In this embodiment, drive assembly 330 also allows for one-way grossaxial adjustment in the second axial direction 310 b (toward end 260 a).In particular, application of an axial tensile load to spindle gear 332parallel to second axial direction 310 b, such as by pulling on boot 350or a handle attached thereto, pulls spindle gear 332 in the seconddirection 310 b, urges flange 335 d in the second axial direction 310 baway from shoulder 334 a, and urges bearing 339 in the second axialdirection 310 b, which axially compresses biasing member 341. The urgingof flange 335 d in the second axial direction 310 b away from shoulder334 a reduces the frictional loads between flange 335 d, washers 337 a,337 b, and shoulder 334 a, which enables spindle 335 to rotate relativeto spindle gear 332 and housing 334 as the external threads of spindlegear 332 are pulled through spindle 335. Thus, as spindle gear 332 ispulled in second direction 310 b through spindle 335, frictional loadsbetween flange 335 d, washers 337 a, 337 b, and shoulder 334 a arereduced, which in turn allow the engagement of mating threads betweenspindle gear 332 and spindle 335 to induce free rotation of spindle 335relative to housing 334 and spindle gear 332. Slip ring 332 d slidinglyengages spindle gear 332 and allows spindle gear 332 to move axiallytherethrough as it is pulled in second direction 310 b. In the mannerdescribed, the axial position of boot 350 along rail 260 can be adjustedin either direction 310 a, 310 b by rotation of hand crank 338, andfurther, the axial position of boot 350 along rail 260 can be adjustedin second axial direction 310 b by applying an axial force in secondaxial direction on boot 350. The former (i.e., rotation of spindle gear332 via crank 338) is generally preferred for fine adjustment of theaxial position of boot 350 in either direction 310 a, 310 b along rail260, whereas the later (i.e., pulling of boot 350 in the second axialdirection) is generally preferred for gross movement of boot 350 in thesecond axial direction 310 b. It should be appreciated that the manualpulling of bot 350 in the second axial direction 310 b can be used toapply fraction to the patient's leg while simultaneously providing somefeel or feedback to the operator of system 10 as to the degree oftraction applied.

Referring now to FIGS. 18-22, boot 350 is configured to support andreleasably retain a patient's foot and ankle. Boot 350 includes a rigidsole 352, and preferably includes straps, belts, snaps or other similardevices for securing a patient's foot therein. In this embodiment, boot350 comprises a sterilizable, non-porous shell having sterile paddingsilicon straps to secure the foot within boot 350 and withstand tractionforces applied to the patient's affected leg.

The heel portion of rigid sole 352 is rotatably coupled to upper end 314a of post 314 with rotatable coupling 316. Thus, boot 350 can becontrollably rotated in either direction about central axis 322 ofcoupling 316. In this embodiment, coupling 316 includes a rigid innerboot plate 360 immediately adjacent and affixed to rigid sole 352, agenerally cylindrical shaft 356 extending perpendicularly from innerplate 360, and a through bore 314 c in the upper end 314 a of post 314.Shaft 356 is rotatably disposed in bore 314 c such that shaft 356, plate360, and boot 350 can be rotated about axis 322 relative to post 314. Abearing, bushing, rollers, etc. can be disposed in bore 314 c betweenshaft 356 and pivot arm 314 to facilitate the smooth rotation of shaft356 relative to pivot arm 314. Axis 322 is coaxially aligned with thecentral axis of shaft 356 and oriented to be generally aligned with andparallel to the patient's tibia when the patient's foot is secured inboot 350. A handle 358 is fixably attached to boot plate 360 and is usedby the users of system 10 to permit manipulation of boot 350 about axes322, 321. Handle 358 may also be utilized to apply gross fraction to thepatient's affected leg by exerting an axial force on handle 358 in thesecond direction 310 b previously described to pull spindle gear 332 andhousing 312 in the second direction 310 b. Referring now to FIGS. 25-27,boot 350 further comprises a release mechanism 380 that releasably locksthe rotation of boot 350 about axis 322. In particular release mechanism380 has a “locked” position preventing rotation of boot 350 about axis322 in either direction and an unlocked position allowing rotation ofboot 350 about axis 322 in either direction. In this embodiment, releasemechanism 380 is biased to the locked position, but can be transitionedto the unlocked position via physical actuation of release mechanism380. In this embodiment, release mechanism 380 includes an intermediateplate 390 moveably coupled to inner plate 360, a cover plate 400disposed over at least a portion of intermediate plate 390, and arotatable handle or paddle 382 pivotably coupled to a support member 384attached to outer plate 390. For purposes of clarity, cover plate 400 ishidden (i.e., not shown) in FIGS. 26 and 27.

Intermediate plate 390 has a central or longitudinal axis 395 and ismoveably positioned between plates 360, 400. In addition, intermediateplate 390 includes a generally circular aperture 392 coaxially alignedwith axes 395, 322 and a pair of elongate apertures 394 orientedparallel to axis 395. Apertures 394 are disposed on opposite sides ofaxis 395. A biasing member 396 is disposed in each aperture 394. Eachbiasing member 396 has a first or upper end 396 a coupled to inner plate356 and a second or lower end 396 b coupled to intermediate plate 390 atthe bottom of the corresponding elongate aperture 394. Circular aperture392 has a radially inner surface 392 a comprising a plurality ofuniformly circumferentially-spaced teeth 392 b along its upper portion.A dial 398 is fixably attached to upper end 314 a of post 314 anddisposed in aperture 392. Shaft 356 extends coaxially through dial 398,which includes a plurality of uniformly circumferentially-spaced teeth398 b disposed along its outer periphery. Teeth 398 b of dial 398 aresized and shaped to releasably engage and interlock with teeth 392 b ofaperture 392. Thus, when teeth 392 b positively engage teeth 398 b,intermediate plate 390 and boot 350 are prevented from rotating aboutaxis 322, however, when teeth 392 b, 398 b are disengaged, intermediateplate 390 and boot 350 can be freely rotated about axis 322. Thus,release mechanism 380 is disposed in the locked position when teeth 392b, 398 b engage one another and is disposed in the unlocked positionwhen teeth 392 b, 398 b are disengaged. In this embodiment, biasingmembers 396 bias teeth 392 b into engagement with teeth 398 b, therebybiasing release mechanism 280 to the locked position.

Paddle 382 is used to transition release mechanism 380 to the unlockedposition by moving intermediate plate 390 axially relative to plates360, 400. In particular, paddle 382 is pivotably coupled to support 384via a pinned connection or pin 386 having a central axis 387perpendicular to axis 322 in top view. Pin 386 is coupled tointermediate plate 390 via a linkage mechanism or link 388 having afirst end 388 a coupled to pin 386 and a second end 388 b pivotablycoupled to translatable plate 390. When paddle 382 is depressed, pin 386is rotated in a counterclockwise direction as shown in FIG. 25, therebycausing link 388 to correspondingly rotate in a counterclockwisedirection. The counterclockwise rotation of link 388 in turn causesintermediate plate 390 to be displaced upwards as shown in FIG. 25 alongaxis 395 due to the pivotable coupling between plate 390 and the secondend 388 b of link 388. As outer plate 390 moves axially upward relativeto dial 398, teeth 392 b are also displaced upward, thereby disengagingteeth 392 b from teeth 398 b of dial 398 and allowing relative rotationbetween plate 390 of boot 350 and dial 380 about axis 322. Further, asintermediate plate 390 is displaced upwards along central axis 395,biasing members 396 are compressed within elongate apertures 394. Thus,upon release of force on paddle 382, biasing members 396 biasintermediate plate 395 axially downwards (relative to axis 395) to thelocked position with teeth 398 b positively engaging teeth 392 b.

Referring to FIGS. 1, 9-12, 23, and 24, drape hanger assembly 222 iscoupled to the upper end 204 a of housing 204 and is configured tosupport and position a drape during a medical procedure using system 10.In this embodiment, drape hanger assembly 222 includes a block or holder224 secured to housing 204, a pair of horizontal drape hangers 228 areleasably secured to holder 224 with locks 226, and a pair of verticaldrape hangers 228 b releasably secured to holder 224 with locks 226. Oneend of each hanger 228 a, 228 b is seated in a mating counterbore inholder 224 and secured therein with one lock 226 and the other end ofeach hanger 228 a, 228 b distal holder 224 includes a loop 228 c for thesecuring a sterilized drape thereto. In this embodiment, each lock 226is a set screw. Although system 10 is shown and described as includingboth horizontal and vertical hangers 228 a, 228 b, respectively, inother embodiments, only incorporate horizontal hangers (e.g., hangers228 a) or vertical hangers (e.g., vertical hangers 228 b), or no hangersat all. Further, although hanger assembly 222 is coupled to housing 204in this embodiment, in other embodiments, the hanger assembly (e.g.,hanger assembly 222) is coupled to the shaft of the base (e.g., shaft208 of base 202) such that the hanger assembly rotates with the shaftabout the central axis of the shaft (e.g., axis 205).

As is known in the art, sterile drapes are used to cover and isolate(i.e., prevent contact with) unsterilized equipment from the patient,surgeon, and medical personnel during a procedure. In general,components positioned below the drape do not necessarily need to besterilized (since they are isolated), while those components positionedon the side of the drape proximal the patient's appendage to be operatedupon and exposed must be sterilized to reduce the potential forinfections. Embodiments described herein can be arranged so that thesterile drape can be positioned over any one or more components ofsystem 10. For example, the entirety of the system 10, including supportassembly 100, rail assembly 200, and foot holder assembly 300 can beexposed, thereby necessitating sterilization of the entire system 10.Alternatively, a sterile drape can be positioned to isolate any one ormore select components of system 10 such that those components need notbe sterilized, while any exposed components must be sterilized.

In an exemplary preferred configuration shown in FIGS. 28-30, a steriledrape 228 d is positioned below sterilized boot 350 and above horizontalrail 260. In particular, the drape 228 d is disposed between blocks 325,326. It should be appreciated that drape 228 d can be positioned betweenblocks 325, 326 before sliding block 326 over block 325 via the dovetailconnection, in which case drape 228 d is squeezed or pinched betweenblocks 325, 326. In such a configuration, only the components of system10, and more specifically the components of foot holder assembly 300,disposed “above” fixed block 325 and drape 228 d need to be sterilized,while the remaining components of system 10 disposed below fixed block325 and drape 228 d need not be sterilized. Even with drape 228 dpinched between blocks 325, 326, boot 350 can be easily and convenientlyremoved via quick release mechanism 327 without disturbing sterile drape228 d or contacting any unsterilized components therebelow. In thismanner, boot 350 may be removed from system 10 or swapped for anotherboot while retaining the position and integrity of sterile drape 228 d.

As shown in FIGS. 29 and 30, the positioning of horizontal drape hangers228 a enable foot holder assembly 300 to be moved up and down along rail250 without allowing sterile drape 228 d to contact the ground, whichwould undesirable compromise the sterility of drape 228 d. Morespecifically, horizontal hangers 228 a are disposed above rail 260 andpositioned on opposite sides of rail 260 in top view. This allows drape228 d to be positioned between blocks 325, 326 and secured to bothhangers 228 a. Drape 228 d is preferably sized and positioned relativeto hangers 228 a and blocks 325, 326 such that there is slack 228 e indrape 228 d between blocks 325, 326 and each hanger 228 a with footholder assembly 300 and rail 260 in an upper position (e.g., uppermostposition) proximal upper end 250 a of vertical rail 250 shown in FIG.29. The slack 228 e in drape 228 d is preferably sufficient such thatfoot holder assembly 300 can be displaced downward to a lower position(e.g., lowermost position) distal upper end 250 a of vertical rail 250as shown in FIG. 30 without placing drape 228 d in tension betweenblocks 325, 326 and either hanger 322 or pulling drape 228 d from eitherhangers 228 a. Further, by clamping opposite ends or lateral sides ofsterile drape 228 d to horizontal rails 228 a, which are positioneddistal the ground, drape 228 d is prevented from touching the ground forany position of foot holder assembly 300 along vertical rail 250.

Referring now to FIGS. 1-4, during an analytical or surgical procedure,the leg support and manipulation system 10 disclosed herein ispositioned adjacent a patient's bed or operating table, and thepatient's foot is secured in boot 350. The patient's foot can then bepositioned and manipulated using system 10 to achieve the desiredpositioning and manipulation of the corresponding affected leg. Legsupport and manipulation system 10 provides a plurality of degrees offreedom for positioning and manipulating the patient's foot, and hencecorresponding leg. For example, post assembly 160 can be extended orcontracted telescopically, shaft 208 can be rotated in either directionto rotate carrier 230 (and hence guide rails 250, 260) about axis 207,carrier 230 (and hence guide rails 250, 260) can be pivoted in eitherdirection about axis 205, mounting block 262 (and hence horizontal guiderail 260) can be moved in either direction along vertical guide rail250, carriage 310 (and hence boot 350) can be moved in either directionalong horizontal guide rail 260, and boot 350 can be rotated in eitherdirection about axes 322 and 326. Each of these movements can beselectively and independently controlled and adjusted. It should also beappreciated that leg support and manipulation system 10 itself can bemoved along the ground to provide yet additional degrees of freedom ofmovement.

In an exemplary procedure, system 10 is positioned adjacent the end ofthe bed supporting the patient's hips. Wheels 126 permit themulti-directional rolling and positioning of the system 10 as desired.Once the desired position of system 10 relative to the patient isachieved, stabilizers 140 are deployed, pads 144 are secured to theground, and wheels 126 are locked with locks 128. Next, the foot of thepatient's operative leg is secured in boot 350. The boot 350 is fastenedaround the foot and ankle of the operative leg such that the operativeleg is at least partially supported by the system 10 and can bepositioned and manipulated with system 10. If necessary before or duringthe procedure, pads 144 can be released from the ground, stabilizersslightly raised about pivot points 142, and wheels 114 unlocked toadjust and reposition system 10. However, prior to subsequentpositioning and manipulation of the patient's operative leg, stabilizers140 are preferably deployed with pads 144 secured to the ground andwheels 126 are preferably locked via locks 128.

With leg support and manipulation system 10 secured at the desiredposition along the ground, boot 350 is positioned and manipulated viaextension or contraction of post assembly 160, rotation of shaft 208about axis 205 in either direction, rotation of boot 350 about axes 322and 326 in either direction, pivoting of carrier 230 in either directionabout axis 213, movement of mounting block 262 in either direction alongvertical guide rail 250, movement of carriage 310 in either directionalong horizontal guide rail 260, or combinations thereof. It should beappreciated that certain motions and combinations of motions result inthe application of traction to the patient's operative leg.

In general, the components of leg support and manipulation system 10 canbe constructed of any suitable material(s), but are preferablyconstructed of material(s) that can be sterilized, for example by anautoclave. Suitable materials include, without limitation, composites,plastics, metals and metal alloys, or combinations thereof. Aspreviously described, leg support and manipulation system 10 is modular,thereby enabling the replacement of worn or damaged parts without havingto replace the entirety of system 10. Such modularity also enables thecomponents of system 10 to be selectively and independently sterilized.This may be particular beneficial in cases where select components areexposed during the procedure (i.e., not covered by sterile drapes), andthus, must be sterilized, while other components are not exposed duringthe procedure (i.e., covered by sterile drapes), and thus, need not besterilized.

While preferred embodiments have been shown and described, modificationsthereof can be made by one skilled in the art without departing from thescope or teachings herein. The embodiments described herein areexemplary only and are not limiting. Many variations and modificationsof the systems, apparatus, and processes described herein are possibleand are within the scope of the invention. For example, the relativedimensions of various parts, the materials from which the various partsare made, and other parameters can be varied. Accordingly, the scope ofprotection is not limited to the embodiments described herein, but isonly limited by the claims that follow, the scope of which shall includeall equivalents of the subject matter of the claims. Unless expresslystated otherwise, the steps in a method claim may be performed in anyorder. The recitation of identifiers such as (a), (b), (c) or (1), (2),(3) before steps in a method claim are not intended to and do notspecify a particular order to the steps, but rather are used to simplifysubsequent reference to such steps.

The invention claimed is:
 1. A system for supporting and manipulating a leg of a patient, the system comprising: a base; a post configured to be positioned at a distal end of the patient, the post having a first end coupled to the base and a second end distal the base; a carrier pivotally coupled to the second end of the post, wherein the carrier is configured to pivot about a horizontal axis relative to the post; a first guide rail coupled to the carrier and configured to pivot with the carrier about a first axis and a second axis relative to the post, wherein the first axis is oriented at an angle relative to the second axis, and wherein the first guide rail has a longitudinal axis; a second guide rail pivotally coupled to the first guide rail, wherein the second guide rail is configured to move axially along the first guide rail; and a boot moveably coupled to the second guide rail, wherein the boot is configured to receive and retain at least a portion of a foot of the patient.
 2. The system of claim 1, further comprising a first lock configured to releasably lock the axial position of the second guide rail along the first guide rail.
 3. The system of claim 2, wherein the lock is a radio frequency identification (RFID) lock.
 4. The system of claim 1, further comprising a second lock configured to releasably lock the angular position of the carrier about the horizontal axis of the post.
 5. The system of claim 1, further comprising a balancing assembly coupled to the first guide rail and configured to exert a torque on the carrier to counterbalance an opposing torque exerted on the carrier by the second guide rail.
 6. The system of claim 1, wherein the post is configured to axially extend and retract.
 7. The system of claim 1, wherein the second guide rail is coupled to a belt rotatably coupled to the first guide rail, wherein the second guide rail configured to move axially along the first guide rail in response to displacement of the belt. 